Differentiators, Data Coverage and Quality
What makes Protocol SmartDesign unique?
Using the power of AI and leveraging the gold standard in clinical trial data, Protocol SmartDesign reduces the time it takes to design a protocol by recommending primary endpoints and I/E criteria to give medical and clinical operations teams a head-start on protocol development. Recommendations are generated based on historical and performance data, learning from what’s worked in past trials —to streamline planning and reduce amendments, creating more successful trials and more predictable timelines.
What types of data are used to inform the Large Language Model's (LLM) recommendations?
Protocol SmartDesign's AI model leverages Citeline's extensive clinical data to deliver comprehensive insights and recommendations, optimizing trial success. A successful trial is defined as one where the actual completion date falls within 60 days of the anticipated completion date. The model is trained on data from:
Over 445,000 clinical trials sourced from 58,000+ data sources.
Trends from trial designs, endpoints, and outcomes across 310+ diseases and 9 therapeutic areas, utilizing ~1,500 endpoints to help differentiate your clinical trial.
Detailed metrics on Primary endpoints, Inclusion and Exclusion criteria, trial timing, enrollment rates, study timelines, to optimize Protocol design.
What does the Protocol SmartDesign algorithm analyze?
Protocol SmartDesign is powered by an AI model trained on the gold standard in clinical trial data, curated by clinical trial experts. Its sophisticated algorithm leverages Machine Learning (ML) and Large Language Models (LLM) to analyze both structured and unstructured historical trial data, generating an accurate predictive model of successful trials.
Industry-sponsored trials
Trials with successful operational outcomes, excluding China-only and COVID-specific studies
Trials where the actual completion date falls within 60 days of the anticipated completion date
What are the key differentiators of Protocol SmartDesign?
Protocol SmartDesign stands out as the most reliable, transparent, and data-driven protocol optimization tool available. Its key differentiators include:
Powered by Citeline’s World-Class Data:
Protocol SmartDesign leverages over 445,000 clinical trials and 58,000+ unique data sources, along with expertly curated datasets spanning 310+ diseases and 9 therapeutic areas. This extensive data foundation ensures recommendations are comprehensive, precise, and rooted in real-world evidence.Unmatched Transparency and Traceability:
Every recommendation is directly linked to its source data, accessible through Trialtrove. Unlike "black box" AI tools, Protocol SmartDesign provides full visibility into the rationale behind its suggestions, allowing you to trust the recommendations with confidence.Time-Saving AI-Powered Efficiency:
By analyzing trends from trial designs, endpoints, and outcomes, Protocol SmartDesign accelerates protocol development. It gives clinical and operational teams a significant head start, reducing the time spent on manual processes and avoiding costly protocol amendments.
Why choose this solution?
Protocol SmartDesign revolutionizes protocol development by combining the power of Citeline’s gold-standard data with advanced AI-driven recommendations. Here’s why this solution is the clear choice for clinical teams:
Data You Can Trust: Every recommendation is rooted in Citeline’s meticulously curated datasets. With direct access to the source data in Trialtrove, you can verify the rationale behind every recommendation, ensuring complete transparency and confidence in your decisions—unlike many other AI tools.
Faster, Smarter Protocol Development: By eliminating manual steps and leveraging sucessful historical trial data, Protocol SmartDesign accelerates protocol design, helping teams finalize their protocols faster while reducing the likelihood of costly amendments.
Tailored for Success: The tool’s recommendations are based on what has worked in successful trials, ensuring protocols are not only feasible but also optimized for recruitment and trial execution.
What AI components are used in Protocol SmartDesign?
Protocol SmartDesign leverages advanced Machine Learning (ML) and Large Language Models (LLM) to deliver data-driven recommendations for protocol development.
How does Protocol SmartDesign save time in protocol development?
Protocol SmartDesign streamlines protocol development by analyzing historical and performance data to recommend primary endpoints and inclusion/exclusion criteria. This approach eliminates the need for manual literature reviews and reduces the likelihood of costly protocol amendments, giving your team a head start and accelerating trial timelines.
Product Questions
What is the definition of a successful trial in Protocol SmartDesign?
A successful trial is defined as one that concludes within 60 days of the target end date and has minimal or no amendments, ensuring operational efficiency and predictability.
What is the rationale behind the definition of 'minimal amendments'?
Historic data shows that protocol amendments typically add four months to a trial’s timeline. By defining success as trials that end within 60 days of the original target date, Protocol SmartDesign ensures recommendations are based on protocols with minimal or no amendments.
Can I view trials that were not operationally successful?
Yes. By clicking the Trialtrove button within Protocol SmartDesign, you can view all trials, including those that were not operationally successful. This allows you to analyze protocol elements associated with trial failures.
How does Protocol SmartDesign determine primary endpoints?
The AI model analyzes studies that include specific endpoints, evaluating their performance, recruitment rates, and overall outcomes. Endpoints that were successfully carried through to trial completion are included, while those removed during trials are excluded.
Can Protocol SmartDesign recommend alternative or similar endpoints?
Yes. The tool categorizes endpoints and suggests other or similar options based on historical success, while less common endpoints are grouped into an “other” category for user review.
Can I upload a protocol into Protocol SmartDesign?
Currently, you cannot upload a protocol, but you can copy and paste endpoints into the results for further analysis. The ability to upload protocols is on our roadmap.
Can I export recommendations into my authoring tool?
Yes. Results, including endpoints and inclusion/exclusion criteria, can be exported into a Word document for easy integration into your preferred authoring tool.
What happens if a drug class has not been previously investigated in the target indication?
Protocol SmartDesign allows users to select proxy categories for drug classes or indications not yet studied. The tool generates recommendations based on similar, successful trials within these proxy categories, helping you design an effective protocol even for uncharted territories.
Does Protocol SmartDesign consider Phase I or exploratory trials?
Yes. The tool is trained on data from all phases of clinical trials, including over 66,000 completed Phase I trials. For diseases with limited Phase I data, it uses disease-level data as a proxy to generate recommendations.